FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
25021-668
11-digit product format
250210668
Labeler code
25021
Product ID
25021-668_507a0145-c6e8-4dcc-8199-3d0674517939
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cisatracurium besylate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA201836
Marketing category
ANDA
Marketing start
2021-11-01
Marketing end
0000-00-00
Substance
CISATRACURIUM BESYLATE
Active strength
2 mg/mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct25021-668DDiscontinued by firm2026-07-31
excluded packagepackage25021-66825021-668-05DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201836-001CISATRACURIUM BESYLATECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-11-06
A201836-002CISATRACURIUM BESYLATECISATRACURIUM BESYLATEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2020-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A201836-001AP
A201836-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201836-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-11-06a50c72e98297…
2026-08-01 22:54:322026-06A201836-002CISATRACURIUM BESYLATEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2020-11-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201836-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A201836-002AP1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25021-668-052021-01-20C16284748780-19d75b9d0-d522-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CISATRACURIUM BESYLATE INJECTION safely and effectively. See full prescribing information for CISATRACURIUM BESYLATE INJECTION. CISATRACURIUM BESYLATE injection, for intravenous use Initial U.S. Approval: 1995
25021-668-052020-01-31C16284748780-19d75b9d0-d522-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CISATRACURIUM BESYLATE INJECTION safely and effectively. See full prescribing information for CISATRACURIUM BESYLATE INJECTION. CISATRACURIUM BESYLATE injection, for intravenous use Initial U.S. Approval: 1995

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-668-05ML - Milliliter25021-66886012f9b-b8c3-4d4a-b383-6b4fb45eb41912014-12-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-668-052502106680510 VIAL in 1 CARTON (25021-668-05) > 5 mL in 1 VIAL10 vial2021-11-010000-00-00NoNoCurrent